Measuring arterial blood volume changes and heart pumping efficiency
Official title: A Pilot Clinical Study to Assess Correlation Between Arterial Blood Volume Status and Cardiac Efficiency, and HemoCept Device Data in Trans-Aortic Valve Replacement (TAVR} Surgery
Run by HemoCept Inc. · NCT07205341 · Data updated 2026-11-12
This pilot will test whether the HemoCept device can detect changes in arterial blood volume and heart pumping efficiency in adults with aortic valve stenosis who are being treated at the participating center.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | HemoCept Inc. Industry-sponsored |
| Locations | 1 site (Boulder, Colorado) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07205341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 80 with aortic valve stenosis who are receiving care at the participating facility and require trans-aortic valve replacement, who can provide informed consent and meet study requirements, are ideal candidates.
✕Probably not a fit
People who are pregnant, breastfeeding, planning pregnancy, or who have a history of long QT syndrome, cardiac channelopathies, or seizures, or who are not undergoing trans-aortic valve replacement at the participating site are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pilot uses the HemoCept device to measure arterial blood volume and indices of cardiac efficiency in adults with aortic valve stenosis who require trans-aortic valve replacement. Participants will be enrolled at a single participating healthcare facility and monitored according to the study protocol before, during, or after valve replacement as specified by investigators. The study seeks to demonstrate the device's ability to detect physiologically meaningful changes rather than to change clinical care. Common exclusions include pregnancy, breastfeeding, and a personal history of long QT syndrome, cardiac channelopathies, or seizures. Consent and HIPAA authorization are required and participants must be treated by the participating site.
Why it matters
Potential benefit: If successful, the HemoCept device could give clinicians a noninvasive way to track arterial blood volume and heart efficiency around valve replacement, potentially improving monitoring and decision-making.
How similar studies have gone: Device-based hemodynamic monitoring approaches have shown promise in research settings, but HemoCept's use for detecting arterial blood volume and cardiac efficiency in this specific patient group is an early, relatively untested pilot.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures. * Subjects can be any gender but must be between (and including) the ages of 18 and 80. * Subject ls being treated by the participating healthcare facility . ., Subject requires a trans-aortic valve replacement. * Subject is able and willing to provide informed consent and HIPM authorization. * Subject is able and willing to meet all study requirements. Exclusion Criteria: * Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study. * Subject has a personal medical history that includes: * Long O-T syndrome * Cardiac channelopathies * Seizures
Where it's running
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Boulder Heart
Boulder, Colorado, United States Recruiting
Study contacts
- Principal investigator: Jamie Doucet, MD — Boulder Heart
- Study coordinator: Katharine Adkins
- Email: kathari.adkins@bch.org
- Phone: 303-442-2395
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
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Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
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CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
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Impact of TAVR on kidney function in people with aortic valve disease
This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.
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Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis
This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.
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How the type of sedation affects recovery after TAVR
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.